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Nevin Manimala Statistics

Efficacy of different exercises in women with fibromyalgia syndrome: a randomised controlled trial

Clin Exp Rheumatol. 2025 Feb 12. doi: 10.55563/clinexprheumatol/uol8so. Online ahead of print.

ABSTRACT

OBJECTIVES: The objective of this study was to evaluate the impact of aerobic exercise, resistance exercise combined with aerobic exercise, and yoga exercises combined with aerobic exercise on pain and disease activity in patients with fibromyalgia syndrome (FM).

METHODS: The study population comprised 60 individuals with FM who met the inclusion criteria. The participants were randomly assigned to one of three groups. The first group underwent aerobic exercise (n=20), the second group combined aerobic exercise with yoga (n=20), and the third group engaged in aerobic and resistance exercise (n=20). All exercise interventions were conducted for a total of 12 weeks. Disease activity was evaluated using the Fibromyalgia Impact Questionnaire (FIQ), while pain status was assessed with the Melzack-Melzack Pain Questionnaire (MMPQ). All assessments were conducted before and following the completion of the exercise program. The clinical trial number of this study is NCT06006494.

RESULTS: The measurements of the aerobic exercise and yoga group were significantly lower than those of the aerobic and resistance exercise group. A statistically significant difference was observed between the groups in terms of post-treatment MMPQ scores. The measurements of the aerobic exercise and yoga group were significantly lower than those of the aerobic exercise only and aerobic and resistance exercise groups. No statistically significant difference was observed between the post-treatment MMPQ scores of the aerobic and aerobic resistance exercise groups.

CONCLUSIONS: The combination of aerobic exercise and yoga is more efficacious in the treatment of FM than aerobic exercise alone or a combination of resistance exercises and aerobic exercise.

PMID:39946182 | DOI:10.55563/clinexprheumatol/uol8so

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Acute-to-chronic ratios of aquatic phototoxicity of polycyclic aromatic hydrocarbons and the prediction of chronic phototoxicity using the phototoxic target lipid model

Environ Toxicol Chem. 2025 Jan 6:vgae069. doi: 10.1093/etojnl/vgae069. Online ahead of print.

ABSTRACT

Polycyclic aromatic hydrocarbons (PAHs) are a group of organic compounds that can be toxic to aquatic life at environmentally relevant concentrations. The toxicity of some PAHs increases in the presence of ultraviolet radiation (UVR). The phototoxic target lipid model (PTLM) builds on the narcotic target lipid model and predicts acute phototoxicity by accounting for the light absorbed by PAHs. Given the lack of chronic data for PAHs exposed to UVR, an acute-to-chronic ratio (ACR) was proposed as a means for extending this model for predicting chronic toxicity. No information could be found on ACRs derived for phototoxic chemicals and therefore, this study had two objectives: (a) to generate acute and chronic toxicity data with and without exposure to UVR; and (b) to test the ability of the PTLM to predict chronic toxicity using an ACR. Acute and chronic bioassays were conducted on eight species, with each exposed to three PAHs and two light treatments: with and without UVR. Although there was a general trend of higher ACRs in UVR treatments, there was no statistical difference across all species in the ACR values for UVR treatments. Data generated herein were combined with data collated through a literature search to generate a global ACR of 11.6. Twenty of the 24 predicted phototoxic effect concentration affecting 10% of species (EC10) values calculated using the PTLM and ACR were within a factor of 10 of the observed phototoxic EC10 or lethal concentration affecting 5% of species values. This study demonstrates the capability of ACR to be applied in the context of phototoxicity and therefore proposes an unprecedented methodology to predict the chronic phototoxicity of PAHs.

PMID:39946179 | DOI:10.1093/etojnl/vgae069

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Prioritizing chemicals of emerging concern in the Great Lakes Basin using covariance of chemical concentrations and diverse biological responses from a variety of species

Environ Toxicol Chem. 2025 Jan 7:vgae094. doi: 10.1093/etojnl/vgae094. Online ahead of print.

ABSTRACT

The Great Lakes Restoration Initiative aims to protect and restore the nation’s largest freshwater resource, in part, by furthering our understanding of the effects of contaminants of emerging concern (CECs) and chemical mixtures on aquatic and terrestrial organisms. To address this goal, an interagency team conducted field studies at sites along the Maumee River in Ohio, USA, in 2016-2017, monitoring CEC levels along with diverse in vitro and in vivo biological effects in ecologically relevant species (fathead minnows, tree swallows, and golden clams). The objective of the present work was to prioritize the CECs in these studies for further monitoring and assessment by determining if there are patterns in chemical-bioeffect relations across data sets, species, and response types that indicate relatively high or low hazard to aquatic life from CEC exposure. Of the 748 monitored chemicals, 425 were detected and were analyzed for covariance with bioeffects. All 748 chemicals were placed into 10 bins based on their frequencies of monitoring, detection, and covariance with bioeffects across studies and species. We describe how chemicals can be prioritized across bins to aid monitoring and assessment efforts. Our approach using effects-based monitoring data is especially useful for prioritizing chemicals with little or no traditional toxicity testing data. Similar evidence-based prioritizations will allow agencies to more efficiently allocate limited resources to improve the ability to protect aquatic and terrestrial organisms from adverse impacts due to contaminant exposure.

PMID:39946177 | DOI:10.1093/etojnl/vgae094

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Daily noise dose and power tool characterization of steel stud framers on commercial construction sites

Ann Work Expo Health. 2025 Feb 13:wxaf005. doi: 10.1093/annweh/wxaf005. Online ahead of print.

ABSTRACT

The construction industry is well-documented as having numerous sources of hazardous noise on the job. Framers who cut and install steel studs on commercial construction sites use a variety of power tools throughout the course of their normal workday and have the potential to be exposed to levels of noise that can lead to occupational noise-induced hearing loss. This study assessed the noise dose of commercial steel stud framers and characterized the noise of common power tools that contribute to their daily noise dose. Occupational exposure limits exist in both required and recommended forms to protect workers; however, large differences in the level of worker protection are apparent between the mandated Occupational Safety and Health Administration (OSHA) permissible exposure limit (PEL) and the voluntary National Institute for Occupational Safety and Health (NIOSH) recommended exposure limit (REL) for noise exposure. Steel stud framers in this study had a mean OSHA PEL dose of 27.6% and a mean NIOSH REL dose of 340.7% for the same workers. As a comparison, ambient equivalent noise doses at the construction site were 1.4% for PEL criteria and 12.4% for REL criteria. Of task assignments during the workday, workers who were assigned primarily as saw operators had statistically significant higher noise exposures than workers who were assigned as stud installers (P = 0.037). Octave band analysis was conducted for full-day exposures and indicated an upward trend of higher noise exposures at higher frequencies. Overall, among all steel stud framers involved in this study, all workers had noise doses below the OSHA PEL (range 5.8% to 61.4%), and all but 2 workers (n = 35) had noise doses above the NIOSH REL (range 63.9% to 823.2%), indicating exposure to hazardous levels of noise based on more protective RELs.

PMID:39946158 | DOI:10.1093/annweh/wxaf005

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US Abortion Bans and Fertility

JAMA. 2025 Feb 13. doi: 10.1001/jama.2024.28527. Online ahead of print.

ABSTRACT

IMPORTANCE: Abortion bans may lead to births among those who are unable to overcome barriers to abortion. The population-level effects of these policies, particularly their unequal impacts across subpopulations in the US, remain unclear.

OBJECTIVE: To assess heterogeneity in the association of abortion bans with changes in fertility in the US, within and across states.

DESIGN, SETTING, AND PARTICIPANTS: Drawing from birth certificate and US Census Bureau data from 2012 through 2023 for all 50 states and the District of Columbia, this study used a bayesian panel data model to evaluate state-by-subgroup-specific changes in fertility associated with complete or 6-week abortion bans in 14 US states. The average percent and absolute change in the fertility rate among females aged 15 through 44 years was estimated overall and by state, and within and across states by age, race and ethnicity, marital status, education, and insurance payer.

EXPOSURE: Complete or 6-week abortion ban.

MAIN OUTCOME AND MEASURES: Fertility rate (births per 1000 reproductive-aged females) overall and by subgroups.

RESULTS: There were an estimated 1.01 (95% credible interval [CrI], 0.45-1.64) additional births above expectation per 1000 females aged 15 through 44 years (reproductive age) in states following adoption of abortion bans (60.55 observed vs 59.54 expected; 1.70% increase; 95% CrI, 0.75%-2.78%), equivalent to 22 180 excess births, with evidence of variation by state and subgroup. Estimated differences above expectation were largest for racially minoritized individuals (≈2.0%), unmarried individuals (1.79%), individuals younger than 35 years (≈2.0%), Medicaid beneficiaries (2.41%), and those without college degrees (high school diploma, 2.36%; some college, 1.58%), particularly in southern states. Differences in race and ethnicity and education across states explain most of the variability in the state-level association between abortion bans and fertility rates.

CONCLUSION AND RELEVANCE: These findings provide evidence that fertility rates in states with abortion bans were higher than would have been expected in the absence of these policies, with the largest estimated differences among subpopulations experiencing the greatest structural disadvantages and in states with among the worst maternal and child health and well-being outcomes.

PMID:39946144 | DOI:10.1001/jama.2024.28527

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Physician Experiences With and Perspectives on Clozapine Prescribing

JAMA Netw Open. 2025 Feb 3;8(2):e2459311. doi: 10.1001/jamanetworkopen.2024.59311.

ABSTRACT

IMPORTANCE: Clozapine is an effective medication for treatment-resistant schizophrenia but can cause agranulocytosis. Since its approval, patients taking clozapine have been required to undergo regular blood testing to screen for neutropenia. In 2015, the risk management programs were merged into a single risk evaluation and mitigation strategy (REMS), which mandates that prescribers undergo a certification process in which they attest to understanding the risk of agranulocytosis and commit to performing required blood testing. It is unknown how the clozapine REMS program has affected clinical practice.

OBJECTIVE: To understand physicians’ perceptions of and experiences with the clozapine REMS program.

DESIGN, SETTING, AND PARTICIPANTS: This survey study included US physicians who prescribed clozapine in 2021 or 2022. A 57-question, closed-field questionnaire was administered via paper or online. The first survey wave took place from May to October 2022 and the second from October 2022 to January 2023.

EXPOSURES: Gender, race and ethnicity, practice specialty, practice setting, practice region, professional time in clinical practice, years since graduation from medical school, and number of patients prescribed clozapine in the past 3 years.

MAIN OUTCOMES AND MEASURES: Experiences with and perceptions of the REMS certification process, patient initiation, and the REMS safe use requirements were measured using Likert scales. Descriptive statistics and multivariable modeling were used to analyze the study results.

RESULTS: Of 750 physicians contacted, 196 responded (30% response rate). Most respondents were male (129 [67%]), most identified as Asian (48 [25%]) or White (124 [63%]), and most were psychiatrists (165 [86%]); almost half (88 [45%]) practiced in an outpatient group setting. Most respondents reported that the information provided during certification was clear (179 [92%]) and contained useful drug information (145 [75%]) and that the paperwork associated with required blood testing facilitated physician-patient conversation (102 [53%]). Most respondents wanted certification materials to include all clinically important risks (172 [89%]) and benefits (139 [72%]) and reported frequent delays in medication access owing to required blood testing (115 [60%]). Two-thirds of respondents agreed that the positives of the certification process (123 [64%]) and blood testing requirements (129 [68%]) outweighed the negatives. In multivariable analysis, negative REMS perceptions were less common among physicians in practice longer (≥35 vs <15 years since medical school: odds ratio [OR], 0.28; 95% CI, 0.10-0.80) and among American Indian or Alaska Native, Black, and Native Hawaiian or Other Pacific Islander physicians compared with White physicians (OR, 0.08; 95% CI, 0.01-0.73).

CONCLUSIONS AND RELEVANCE: In this survey study of physician prescribers of clozapine, a majority were satisfied with the clozapine REMS program but highlighted the need for enhanced educational materials and administrative efficiency.

PMID:39946132 | DOI:10.1001/jamanetworkopen.2024.59311

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Trends in Axillary Lymph Node Dissection After Mastectomy Among Patients With Limited Nodal Burden

JAMA Netw Open. 2025 Feb 3;8(2):e2459692. doi: 10.1001/jamanetworkopen.2024.59692.

ABSTRACT

IMPORTANCE: Current practices in axillary treatment for patients with breast cancer who receive a mastectomy for node-positive disease are unknown. For patients who receive postmastectomy radiotherapy (PMRT), the addition of axillary lymph node dissection (ALND) may result in significant overtreatment.

OBJECTIVES: To evaluate trends in axillary treatment for patients with limited nodal metastases who receive a mastectomy and identify factors that can be targeted to reduce axillary overtreatment.

DESIGN, SETTING, AND PARTICIPANTS: A retrospective cohort study was conducted of patients identified from the National Cancer Database who received a diagnosis of breast cancer from January 1, 2012, to December 31, 2021. Patients included were women aged 18 years or older with clinical (c) T1-T2N0 breast cancer who underwent mastectomy with axillary staging with sentinel lymph node biopsy (SLNB) and/or ALND and had 1 to 2 positive lymph nodes. Patients who received neoadjuvant therapies were excluded. Statistical analysis was performed from December 2023 to July 2024.

EXPOSURE: Axillary management based on ALND and PMRT receipt: (1) ALND alone, (2) PMRT alone, (3) both ALND and PMRT, and (4) neither ALND nor PMRT.

MAIN OUTCOMES AND MEASURES: Axillary management strategies were evaluated, and clinicopathologic characteristics based on treatment type were compared with multivariable analysis.

RESULTS: In total, 62 332 patients were included (median age, 58 years [IQR, 48-68 years]; 82.2% with Charlson-Deyo comorbidity score 0). The proportion of patients who received ALND alone decreased from 47.1% to 17.6% from 2012 to 2021, while the percentage of patients who received PMRT alone increased from 9.8% to 36.8%. Overall, 21.3% of patients received treatment with both ALND and PMRT, with little change over time (from 21.7% in 2012 to 17.7% in 2021). Most patients (88.4%) who received both PMRT and ALND underwent ALND at the same operation as SLNB. Younger age (odds ratio [OR] per year increase, 0.98 [95% CI, 0.98-0.98]; P < .001), high-grade tumors (grade 2: OR, 1.18 [95% CI, 1.09-1.29]; P < .001; grade 3: OR, 1.34 [95% CI, 1.22-1.48]; P < .001), presence of lymphovascular invasion (OR, 1.26 [1.19-1.33]; P < .001), and larger tumor size (cT2 tumors compared with cT1: OR, 1.10 [95% CI, 1.03-1.17]; P = .004; upstaging to pathologic T3 tumors: OR, 2.29 [95% CI, 1.15-4.99]; P = .03) were associated with increased likelihood of concurrent treatment with ALND and PMRT.

CONCLUSIONS AND RELEVANCE: In this retrospective cohort study of patients with breast cancer who received a mastectomy, a substantial proportion of those with 1 to 2 positive lymph nodes were treated with both ALND and PMRT. Delaying the decision for ALND until after multidisciplinary input may reduce overtreatment.

PMID:39946126 | DOI:10.1001/jamanetworkopen.2024.59692

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Trends in Obesity-Related Measures Among US Children, Adolescents, and Adults

JAMA. 2025 Feb 13. doi: 10.1001/jama.2024.27676. Online ahead of print.

NO ABSTRACT

PMID:39946125 | DOI:10.1001/jama.2024.27676

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US Abortion Bans and Infant Mortality

JAMA. 2025 Feb 13. doi: 10.1001/jama.2024.28517. Online ahead of print.

ABSTRACT

IMPORTANCE: The impact of recent abortion bans on infant mortality is not fully understood. There is also limited evidence on how these bans may interact with long-standing racial and ethnic disparities in infant health.

OBJECTIVE: To examine the association of abortion bans with changes in infant mortality and to compare this association in racial and ethnic groups based on analyses within and across states.

DESIGN, SETTING, AND PARTICIPANTS: This population-based, serial, cross-sectional study used a bayesian panel model to examine infant mortality rates in 14 states that implemented complete or 6-week abortion bans and compared them with predictions of infant mortality rates based on pre-ban mortality rates and states without bans. Data included all live births and infant deaths from all 50 US states and the District of Columbia for 2012 through 2023. Models accounted for temporal trends and state-specific factors, with analyses stratified by race and ethnicity, timing of death, and cause of death.

EXPOSURE: Complete or 6-week abortion bans.

MAIN OUTCOME AND MEASURES: Infant mortality rate, analyzed overall and by subgroups.

RESULTS: The analysis found higher than expected infant mortality in states after adoption of abortion bans (observed vs expected, 6.26 vs 5.93 per 1000 live births; absolute increase, 0.33 [95% credible interval (CrI), 0.14-0.51]; relative increase, 5.60% [95% CrI, 2.43%-8.73%]). This resulted in an estimated 478 excess infant deaths in the 14 states with bans during the months affected by bans. The estimated increases were higher among non-Hispanic Black infants compared with other racial and ethnic groups, with 11.81 observed vs 10.66 expected infant deaths per 1000 live births, an absolute increase of 1.15 (95% CrI, 0.53-1.81) and relative increase of 10.98% (95% CrI, 4.87%-17.89%). The observed infant mortality rate due to congenital anomalies was 1.37 vs 1.24 expected (absolute increase, 0.13 [95% CrI, 0.04-0.21]; relative increase, 10.87% [95% CrI, 3.39%-18.08%]), while the rate not due to congenital anomalies was 4.89 observed vs 4.69 expected (absolute increase, 0.20 [95% CrI, 0.02-0.38]; relative increase, 4.23% [95% CrI, 0.49%-8.23%]). Texas had a dominant influence on the overall results and there were larger increases in southern vs nonsouthern states.

CONCLUSIONS: US states that adopted abortion bans had higher than expected infant mortality after the bans took effect. The estimated relative increases in infant mortality were larger for deaths with congenital causes and among groups that had higher than average infant mortality rates at baseline, including Black infants and those in southern states.

PMID:39946113 | DOI:10.1001/jama.2024.28517

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Lumateperone for the Treatment of Major Depressive Disorder With Mixed Features or Bipolar Depression With Mixed Features: A Randomized Placebo-Controlled Trial

J Clin Psychopharmacol. 2025 Feb 14. doi: 10.1097/JCP.0000000000001964. Online ahead of print.

ABSTRACT

BACKGROUND: This randomized, double-blind, placebo-controlled trial (ClinicalTrials.gov identifer NCT04285515) evaluated efficacy and safety of lumateperone to treat major depressive episodes (MDEs) associated with major depressive disorder (MDD) or bipolar depression with mixed features.

PROCEDURES: Patients (18-75 years) with Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)-defined MDD with mixed features (n = 185) or bipolar disorder with mixed features (n = 200) and experiencing an MDE were randomized 1:1 to 6-week placebo (n = 195) or lumateperone 42 mg (n = 193). Primary and key secondary endpoints were change from baseline to day 43 in Montgomery-Åsberg Depression Rating Scale Total and Clinical Global Impression Scale-Severity (CGI-S) scores in 3 populations with combined MDD/bipolar depression, individual MDD, and individual bipolar depression. Safety included adverse events (AEs), extrapyramidal symptoms, and laboratory parameters.

RESULTS: Lumateperone met the primary endpoint, significantly improving Montgomery-Åsberg Depression Rating Scale total score at day 43 in populations with combined MDD/bipolar depression (least squares mean difference vs placebo [LSMD], -5.7; 95% confidence interval [CI], -7.60,-3.84; effect size [ES], -0.64; P < 0.0001), MDD (LSMD, -5.9; 95% CI, -8.61,-3.29; ES, -0.67; P < 0.0001), and bipolar depression (LSMD, -5.7; 95% CI, -8.29,-3.05; ES, -0.64; P < 0.0001). Lumateperone significantly improved CGI-S and Young Mania Rating Scale total scores at day 43 in these populations. Lumateperone was well-tolerated. Treatment-emergent AEs (≥5%, twice placebo) in the combined population were somnolence (placebo, 1.6%; lumateperone, 12.5%), dizziness (placebo, 2.1%; lumateperone, 12.0%), and nausea (placebo, 1.6%; lumateperone, 9.9%). There were no mania/hypomania treatment-emergent AEs with lumateperone and minimal extrapyramidal symptoms or metabolic risk.

CONCLUSIONS: Lumateperone 42 mg significantly improved depression symptoms and disease severity and was generally safe and well-tolerated in patients with MDD or bipolar depression with mixed features.

PMID:39946099 | DOI:10.1097/JCP.0000000000001964